Plenaxis

"The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

Plenaxis

Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)

Indications

Dosage

How Supplied

INDICATIONS

Plenaxis™ is indicated for the palliative treatment of men with advanced
symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate
and who refuse surgical castration, and have one or more of the following: (1)
risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone
pain from skeletal metastases persisting on narcotic analgesia.

DOSAGE AND ADMINISTRATION

For safety reasons, Plenaxis™ is approved with marketing restrictions.
Only physicians who attest to the following qualifications and accept the following
responsibilities, and on that basis enroll in PRAECIS PHARMACEUTICALS INCORPORATED's
Plenaxis™ PLUS Program should prescribe Plenaxis™ . PRAECIS PHARMACEUTICALS
INCORPORATED and its agents will provide Plenaxis™ to physicians enrolled
in the Plenaxis™ PLUS Program.

have access to medication and equipment necessary to treat allergic reactions,
including anaphylaxis.

have patients observed for development of allergic reactions for 30 minutes
following each administration of Plenaxis™ .

understand the risks and benefits of palliative treatment with Plenaxis™ ,
including information from the Package Insert, Patient Information, and the
Physician Attestation.

educate the patients on the risks and benefits of treatment with Plenaxis™
and obtain the patient's signature on the Patient Information signature page,
sign it, and place the original signed form in the patient's medical record,
and give a copy of the Patient Information leaflet with the signed page to
the patient.

report serious adverse events, such as any immediate-onset systemic allergic
event (including anaphylaxis, hypotension, and syncope) as soon as possible
to PRAECIS PHARMACEUTICALS INCORPORATED at 1-866-PLENAXIS (1-866-753-6294) or
to the Food and Drug Administration's MedWatch Program at 1-800-FDA-1088.

understand that they may withdraw their enrollment in the Plenaxis™ Prescribing
Program by a written statement submitted to PRAECIS PHARMACEUTICALS INCORPORATED
(contact information below) or that PRAECIS PHARMACEUTICALS INCORPORATED may
withdraw physicians from the Plenaxis™ PLUS Program if they do not meet
the agreed upon responsibilities.

To enroll in the Plenaxis™ Prescribing Program call 1-866-PLENAXIS (1-866-753-6294)
or visit www.plenaxisplus.com.

Dose: The recommended dose of Plenaxis™ is 100 mg administered
intramuscularly to the buttock on Day 1, 15, 29 (week 4) and every 4 weeks thereafter.
Treatment failure can be detected by measuring serum testosterone concentrations
just prior to Plenaxis™ administration, beginning on Day 29 and every
8 weeks thereafter.

Directions for Reconstituting and Administering Plenaxis™

Read the instructions completely before performing reconstitution.

The sterile powder for suspension is to be reconstituted in accordance with
the following directions:

Reconstitution Instructions for 1 Vial of Plenaxis™ to Provide a 100
mg (50 mg/mL) Dose as a Single IM Injection

Use aseptic technique throughout.

Prior to reconstitution, gently shake the vial of Plenaxis™ (abarelix
for injectable suspension). Hold the vial at an angle (45 degrees) and tap lightly
on table to break up any caking.

Shake for approximately 15 seconds. Allow the vial to stand for approximately
2 minutes. Tap the vial to reduce foaming and swirl the vial occasionally.

Again, shake for approximately 15 seconds. Allow the vial to stand for
approximately 2 minutes. Tap the vial to reduce foaming and swirl the
vial occasionally.

Picture 3

Do not reinject the air into the vial. Locate a second injection spot
on the stopper, and then insert the 18 G needle. Invert the vial and draw up
some of the suspension into the syringe and without removing the needle from
the vial reinject it at any remaining solids in the vial. Repeat the process
until all solids are dispersed.

Swirl the vial before withdrawal and withdraw the entire contents (at least
2 mL) by positioning the needle at a 45 degree angle as shown in the picture.

Picture 4

Pull the plunger back to recover the residual suspension in the 18 G x1½”
needle.

Storage

HOW SUPPLIED

The physician must attest to meeting the qualifications and accepting the responsibilities
in the DOSAGE AND ADMINISTRATION section of this package insert by submitting
the Physician's Attestation form to PRAECIS PHARMACEUTICALS INCORPORATED to
be enrolled in the Plenaxis™ PLUS Program. PRAECIS PHARMACEUTICALS INCORPORATED
and its agents will only provide Plenaxis™ to physicians enrolled in the
Plenaxis™ Prescribing Program. Plenaxis™ vials are not to be resold
or redistributed.